NCT00364039已完成1 期
A Phase 1 Double-Blind, Placebo-Controlled Single Center Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single Dose and Multiple Dose Escalations of AV650 in Healthy Subjects
Avigen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of AV650 in healthy subjects given single and multi-doses under fasted and fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoking
- •Body mass index between 18.5 and 29.9 kg/m2 or body mass index greater than 29.9 kg/m2 with good to excellent body fat percentage
排除标准
- •Known hypersensitivity to lidocaine or non-steroidal anti-inflammatory agents (NSAIDS)
- •History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric disease
- •History of HIV or Hepatitis B
- •History of symptomatic hypotension
- •History of mental illness, drug addiction, drug abuse or alcoholism
- •History of cancer
- •History of inflammatory arthritis (rheumatoid, lupus, psoriatic arthritis)
- •Current use of immunosuppressive therapy (systemic steroids, cyclosporine) or use of nasal or topical steroids
- •History of gastric or duodenal ulcer disease
- •History of severe physical injury, direct impact trauma or neurological trauma within 6 months of Study Day 1
- •Female subjects who are pregnant or nursing
- •Have donated blood within 90 days of Study Day -1
- •Have received an investigational drug within 90 days of Screening
- •Require regular use of antihistamines, H2 blockers (such as cimetidine, ranitidine), TCAs or SSRIs or who have taken these medications witin 14 days of Study Day 1
结局指标
主要结局
Safety
Tolerability
次要结局
- Pharmacokinetic profile
- Sedation and reaction time changes
研究者
研究点 (2)
Loading locations...
相似试验
终止
1 期
Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001)Coronavirus Disease (COVID-19)NCT04569786Merck Sharp & Dohme LLC232
已完成
2 期
Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy PatientsDuchenne Muscular DystrophyNCT01396239Sarepta Therapeutics, Inc.12
终止
3 期
Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary HypercholesterolemiaHypercholesterolemiaNCT00718965Sanofi826
已完成
1 期
Activity of AVE1625 in Mild to Moderate Alzheimer's Patients.Alzheimer DiseaseNCT00380302Sanofi162
已完成
1 期
A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic FibrosisCystic FibrosisNCT03029455Vertex Pharmaceuticals Incorporated163